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Lumbo-Sacral back brace
EUDAMEDClass I (EU MDR)
Ref BS015Model BS001 BS002 BS003 BS004 BS005 BS006 BS007 BS008 BS009 BS010 BS011 BS012 BS015 BS016 BS017 BS018 BS019 BS020 BS021 BS022 BS023 BS024 BS025 BS026 BS027
Identity
- Device Name
- Lumbo-Sacral back brace EUDAMED
- Model / Reference
- BS001 BS002 BS003 BS004 BS005 BS006 BS007 BS008 BS009 BS010 BS011 BS012 BS015 BS016 BS017 BS018 BS019 BS020 BS021 BS022 BS023 BS024 BS025 BS026 BS027 EUDAMEDBS015 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975816761466 EUDAMED
- Basic UDI-DI
- 697581676LSBB0012K EUDAMED
- EMDN Code
- Y061219 CHEST-LUMB-SACRAL-HIP-KNEE-ANKLE-FOOT ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Lumbo-Sacral back brace by Xiamen Huakang Orthopedic Co., Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697581676LSBB0012K | Class I | Active |
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Manufacturer
- Manufacturer
- Xiamen Huakang Orthopedic Co., Ltd
- EUDAMED SRN
- CN-MF-000002290
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (1)
- EUDAMED 2037bc84-9eaf-40f1-98e0-af2b4153ec75 61 fields · synced Jun 19, 2026